DGAP-News: AiCuris Anti-infective Cures GmbH / Key word(s): Study
results/Study
AiCuris' licensee MSD says Letermovir, an investigational prophylactic
therapy against HCMV in bone marrow transplant patients, met Primary
Endpoint in Pivotal Phase III Study
19.10.2016 / 13:15
The issuer is solely responsible for the content of this announcement.
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AiCuris' licensee MSD says Letermovir, an investigational prophylactic
therapy against HCMV in bone marrow transplant patients, met Primary
Endpoint in Pivotal Phase III Study
Wuppertal, Germany, October 19, 2016 - AiCuris Anti-infective Cures GmbH, a
leading company in the discovery and development of drugs against
infectious diseases, today announced, in reference to a news release issued
by licensee MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA),
that letermovir, an investigational antiviral medicine, met the primary
endpoint in the pivotal phase III study. The global, multicenter,
randomized, placebo-controlled trial was designed to evaluate the efficacy
and safety of letermovir for the prevention of clinically-significant
cytomegalovirus (CMV) infection in adult (18 years and older) CMV-
seropositive recipients of an allogeneic hematopoietic stem cell transplant
(HSCT). MSD will present top line results from this study at an upcoming
scientific conference.
Since foundation in 2006, AiCuris has been developing letermovir through
phase II studies prior to licensing the antiviral medicine to MSD in 2012.
Dr. Holger Zimmermann, CEO of AiCuris Anti-infective Cures GmbH comments:
"The positive outcome of this study is an important milestone for our
company. It's a long journey with many challenges to develop new drugs.
Today's news validates our scientific expertise and our capabilities to
discover and develop new therapies. These results make me proud of our
team, which has worked hard for many years with great commitment and
dedication and I am very thankful for the confidence our investors place in
us."
Dr. Thomas Strüngmann, who, together with his brother has been the main
investor in the Company, is very pleased with the AiCuris team about these
positive results. "Taking such long term investment strategies is often
considered risky. We look forward to further good news from the other
projects of our Company's pipeline." Thomas wants also to take the
opportunity to thank Bayer for the good long-term relationship and trust
when he took over the anti-infective spin-out which became AiCuris.
Prof. Dr. Helga Rübsamen-Schaeff, the founding CEO of AiCuris Anti-
infective Cures GmbH and current Chair of the Scientific Advisory Board,
noted: "The letermovir program is a good example of our dedicated research
and development strategy, which over many years was committed to finding
novel mechanisms of action against CMV. This resulted in the innovative
chemical molecule under investigation, letermovir, which targets the viral
terminase protein. I am very happy that the pivotal phase III study with
letermovir met its primary endpoint."
AiCuris received a EUR110 million upfront payment in 2012 under the
licensing agreement with MSD, and under the terms of the agreement, will
receive future payments if specific milestones are achieved as well as post
approval and market launch royalty payments.
Please follow the link to the news release issued today by MSD:
http://www.mercknewsroom.com/news-release/corporate-news/merck-announces-p
ivotal-phase-3-study-letermovir-investigational-antivir
About Letermovir
Letermovir is an investigational once-daily antiviral medicine under
development for the prevention of CMV infection and disease. It is a member
of a new class of non-nucleoside CMV inhibitors (3,4 dihydro-quinazolines)
and inhibits viral replication by targeting the viral terminase complex.
Letermovir has been granted orphan designation by the European Medicines
Agency, the U.S. Food and Drug Administration (FDA) and the Japanese
Ministry of Health, Labour and Welfare for the prevention of CMV infection
and disease in at-risk populations. Letermovir also has been granted Fast
Track designation by the FDA.
In 2012, AiCuris granted worldwide rights to further develop and
commercialize letermovir (AIC246) to MSD after successful completion of a
clinical phase IIb trial.
About HCMV
The Human Cytomegalovirus (HCMV) is widely spread in the human population
and represents an important pathogen for immunocompromised individuals.
HCMV infection is characterized by fever, leucopenia (very low white blood
cell count) and thrombocytopenia (very low platelet numbers) with or
without specific organ dysfunction. Two main strategies to prevent HCMV
infection have been adopted: anti-HCMV drug prophylaxis or pre-emptive
treatment of transplant recipients who are at risk and have evidence of
HCMV infection upon screening.
About AiCuris Anti-infective Cures GmbH
AiCuris was founded in 2006 as a spin-off from Bayer and focuses on the
discovery and development of drugs against infectious diseases. The
company's majority investor is SANTO Holding. The company is developing
drugs for the treatment of viruses such as human cytomegalovirus (HCMV),
herpes simplex virus (HSV), hepatitis B virus (HBV), and adenovirus. In the
field of antibacterials, AiCuris seeks to develop innovative treatment
options for life-threatening, (multidrug-)resistant hospital-treated
pathogens. In 2012, AiCuris signed a license agreement with MSD, one of the
largest agreements of its kind in the European biotech industry. The
agreement covers the development and commercialization of novel drug
candidates against HCMV. Letermovir, the most advanced compound under this
agreement, met the primary endpoint in a pivotal phase III clinical trial
in patients undergoing bone marrow transplantation.
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Contact:
Media Relations
AiCuris Anti-infective Cures MC Services AG
GmbH
Katja Woestenhemke Anne Hennecke
Friedrich-Ebert-Str. 475/Geb. Kaiser-Friedrich-Ring 5
302
42117 Wuppertal 40545 Düsseldorf
Phone +49 202 317 63 0 Phone +49 211 529 252 22
Fax +49 202 317 63 1601 Fax +49 211 529 252 29
Email business@aicuris.com Email anne.hennecke@mc-services.eu
Web www.aicuris.com Web www.mc-services.eu
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512769 19.10.2016
DGAP-News: AiCuris' licensee MSD says Letermovir, an investigational prophylactic therapy against HCMV in bone marrow transplant patients, met Primary Endpoint in Pivotal Phase III Study
| Source: EQS Group AG